Items related to Biologics Development: A Regulatory Overview
Synopsis
Written by industry experts and officials at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), this book provides a comprehensive review of FDA’s emerging processes for regulating and approving biological products. An extensive examination of FDA’s regulation of biologic products, from preclinical testing to postmarketing regulatory requirements and from user fees to electronic submissions is presented. It also evaluates the consolidation and transfer of specific biologic product reviews from CBER to CDER.
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Search results for Biologics Development: A Regulatory Overview
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Biologics Development: A Regulatory Overview
Seller: World of Books (was SecondSale), Montgomery, IL, U.S.A.
Seller rating 5 out of 5 stars
Hardback. Condition: Very Good. This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products. Seller Inventory # 00095161819
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Biologics Development: A Regulatory Overview
Seller: Your Online Bookstore, Houston, TX, U.S.A.
Seller rating 5 out of 5 stars
Hardcover. Condition: Fair. Seller Inventory # 1882615670-4-26639192
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Biologics Development: A Regulatory Overview
Seller: ThriftBooks-Phoenix, Phoenix, AZ, U.S.A.
Seller rating 5 out of 5 stars
Hardcover. Condition: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1882615670I4N00
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Biologics Development: A Regulatory Overview
Seller: ThriftBooks-Atlanta, AUSTELL, GA, U.S.A.
Seller rating 5 out of 5 stars
Hardcover. Condition: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1882615670I4N00
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Biologics Development: A Regulatory Overview
Seller: ThriftBooks-Atlanta, AUSTELL, GA, U.S.A.
Seller rating 5 out of 5 stars
Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1882615670I3N00
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Biologics Development: A Regulatory Overview
Seller: ThriftBooks-Dallas, Dallas, TX, U.S.A.
Seller rating 5 out of 5 stars
Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1882615670I3N00
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Biologics Development: A Regulatory Overview
Published by
Barnett Educational Services / Chi (edition 3), 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
Used
Hardcover
Seller: BooksRun, Philadelphia, PA, U.S.A.
Seller rating 5 out of 5 stars
Hardcover. Condition: Very Good. 3. It's a well-cared-for item that has seen limited use. The item may show minor signs of wear. All the text is legible, with all pages included. It may have slight markings and/or highlighting. Seller Inventory # 1882615670-11-1
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Biologics Development: A Regulatory Overview
Seller: World of Books Inc, Montgomery, IL, U.S.A.
Seller rating 4 out of 5 stars
Hardback. Condition: Very Good. This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products. Seller Inventory # CIN1882615670VG
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Biologics Development: A Regulatory Overview
Published by
Barnett Educational Services / Chi, 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
Used
Hardcover
Seller: Bay State Book Company, North Smithfield, RI, U.S.A.
Seller rating 5 out of 5 stars
Condition: good. The book is in good condition with all pages and cover intact, including the dust jacket if originally issued. The spine may show light wear. Pages may contain some notes or highlighting, and there might be a "From the library of" label. Boxed set packaging, shrink wrap, or included media like CDs may be missing. Seller Inventory # BSM.1BVGJ
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Biologics Development: A Regulatory Overview
Published by
Barnett Educational Services / Chi, 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
Used
Hardcover
Seller: Better World Books, Mishawaka, IN, U.S.A.
Seller rating 5 out of 5 stars
Condition: Good. Pages intact with minimal writing/highlighting. The binding may be loose and creased. Dust jackets/supplements are not included. Stock photo provided. Product includes identifying sticker. Better World Books: Buy Books. Do Good. Seller Inventory # 57084313-6